Overview
Senior Manager of Process Improvement & Stewardship – First Liters and Fractionation at Takeda Pharmaceutical (Italy).
Responsibilities
- Manage the activities related to the Process Improvement & Stewardship Team, ensuring alignment with business objectives and efficient operation.
- Lead process improvement initiatives, monitoring, and stewardship.
- Provide technical support about manufacturing processes, investigations, optimization, yield improvement projects, and cycle time reduction; ensure process robustness and Technology Transfer where applicable.
- Oversee product and process investigations, product impact assessment, and risk assessment.
- Collaborate with all departments to ensure an integrated and cohesive approach.
- Ensure compliance with regulations and quality standards; keep Quality by Design documents up to date.
- Manage process validation strategy.
- Support the preparation of regulatory submissions/meetings and regulatory inspections; defend technical decisions to regulatory agencies.
Core Elements Related to this Role
- Excellent leadership and team management skills.
- Strong strategic orientation and analytical thinking ability.
- Excellent communication, collaboration, and influencing skills.
- Experience in managing complex projects and implementing innovative technologies.
- Ability to anticipate changes and solve complex problems.
- Project management skills and results orientation.
- Development of the team, providing strategic direction and support in complex scenarios.
- Development of strategic plans for departmental growth and operational efficiency.
Technical/Functional Requirements
- Master or PhD degree in technical/scientific fields (preferably pharmaceutical sciences, chemistry, biotechnology, bioinformatics or pharma-process engineering).
- 5/7 years of leadership experience.
- Previous experience in plasma fractionation processes (ideal) or biotechnology; knowledge of proteins; mandatory GMP/GDP.
- Experience in Process Validation (Preferred).
- Experience in process optimization and implementing productivity-enhancing strategies.
- Proficiency in continuous improvement processes.
- Proven experience in statistics/data analysis or equivalent academic experience.
- Proven knowledge of Six Sigma and DMAIC methodology.
- Fluent in Italian and English (written and spoken).
Leadership & Decision-Making
- Focus on priorities and deliver superior results.
- Elevate organizational capabilities for now and the future.
- Strategic thinking to serve patients and build trust; understand industry trends and market conditions.
- Strong organizational, communication, presentation, and influencing skills.
- Ability to create clarity, foster alignment, and make or escalate decisions with sound business judgment.
Additional Information
- Willingness to travel to internal/external Takeda meetings and events.
What Takeda Can Offer
We provide world-class benefits and resources to support employees in work, home, and community life.
- Health and Finance
- Health Care Assistance Insurance
- Employee Stock Purchase Plan
- Employee discount programs on goods and services
- Training and Development
- Technical skill training and professional development
- Job rotation programs
- Diversity, Equity, and Inclusion initiatives
- Individual Support
- Wellness programs
- On-site cafeteria and facilities
- Resources for mental, physical, financial, and spiritual health
- Note
- Belonging to protected categories will be considered a preferential qualification.
Important Considerations
In this role you may work in a controlled manufacturing environment requiring gowning and protective clothing; removal of makeup, jewelry, contact lenses, nail polish, or artificial nails may be required while in the manufacturing environment.
More About Us
Takeda is a patient-focused company committed to quality, safety, and excellence. We value diversity and provide equal employment opportunities to all applicants.
Locations
ITA - Rieti
Worker Type
Employee